FDA 510(k) clearances — page 1373
clearances on record, most recent first.
Clearances — page 1373
137,201–137,300 of 175,890- K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS
- K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST
- K874838 — COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
- K874858 — LASERTRIPTER MINISCOPE
- K874872 — FRESENIUS HEMOFLOW F3, F4, F5, F7
- K874922 — ACUSON TRANSPERINEAL NEEDLE GUIDE
- K874945 — CEMENT LINER
- K875033 — STERILE SCRUBBY SCRUB BRUSH
- K875087 — PEYMAN G. 12.12 YAG LASER LENS
- K875114 — HOSKINS-BARKAN GONIOTOMY LENS 9MM
- K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM
- K875124 — LOW-POWER BINOCULAR LOUPE
- K875214 — A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
- K875312 — UFR DIGITAL RETROFIT
- K880084 — GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
- K880292 — FACTOR VIII REFERENCE PLASMA
- K880297 — SEA - PORT INFUSION SET
- K880302 — CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
- K880327 — MARLEN ULTRA ILEOSTOMY POUCH-5000
- K880385 — KIMBERLY-CLARK PROFESSIONAL JACKET
- K880538 — TRACK AND CARRIER, INTRAVENOUS
- K871852 — COXA ACETABULAR CUP
- K871912 — PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
- K872632 — DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
- K873032 — GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
- K873550 — DSL ACTIVE ESTRADIOL RIA (DSL #4300)
- K873762 — SERIES 77000 ULTRASOUND IMAGING SYSTEM
- K874362 — AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
- K874442 — DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
- K874500 — GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
- K874727 — PRECEPT(TM) CIPROFLOXACIN
- K874731 — LYPHOCHEK WHOLE BLOOD CONTROL
- K874763 — CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
- K874808 — COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
- K874874 — ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
- K874882 — ACROMED CROSS ROD CONNECTOR
- K874899 — CANYON MEDICAL FEMORAL BYPASS CANNULAE
- K874948 — SUN MEDICAL SMOKE EVACUATOR SYSTEM
- K875048 — SARNS VENOATRIAL CATHETER
- K875071 — ASPARTATE AMINOTRANSFERASE AST/SGOT
- K875129 — STERI-CLENS
- K875153 — THIELER KIT
- K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
- K875272 — SONOLINE CF
- K875325 — MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK
- K875326 — MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER
- K880004 — TOWNLEY COX COMB ACETABULAR CUP
- K880151 — HIP, FEMUR AND HUMERUS RETRACTOR
- K880166 — BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
- K880176 — HDL CHOLESTEROL PRECIPITATING REAGENT
- K880178 — CREATINE KINASE (COLORIMETRIC METHOD)
- K880214 — TSRH H/M TORQUE LIMITING WRENCH
- K880215 — TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
- K880227 — ARTHROBOT(TM) LOWER LIMB POSITIONER
- K880265 — WEHBE ARM HOLDER
- K880266 — MULTI-ENZYME LINEARITY SOLUTION
- K880282 — LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
- K880331 — HOOK PUNCH FORCEPS FOR ARTHROSCOPY
- K880405 — SILASTIC NASAL IMPLANT S-TYPE
- K880436 — MICROTRAK HSV CULTURE IDENTIFICATION TEST
- K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
- K873331 — ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
- K874541 — RRT TOTAL IGE TEST KIT
- K874619 — SPECTRON EF ACETABULAR COMPONENT
- K874633 — PERMCATH INSERTION TRAY
- K874776 — ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
- K874802 — FLIPSCREEN QAT
- K874830 — MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
- K874860 — ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.
- K874893 — MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR
- K875161 — MAT (TM) MICROALBUMIN TEST
- K875201 — PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
- K875223 — DANNINGER ORTHOPAEDIC AWL
- K875254 — GULLSORB IGG INACTIVATION REAGENT
- K875274 — TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
- K875282 — QM300 CALIBRATOR B PACK
- K875315 — I.V. START KITS
- K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
- K875360 — THE BELTONE 2000 AUDIOMETER
- K880002 — MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
- K880045 — ACROMED AWL/PUNCH, DEPTH GAUGE
- K880156 — VOLZ TOTAL WRIST PROSTHESIS
- K880324 — MICRO-AIRE CEMENT REMOVAL TOOLS
- K880341 — N-IMMUNOGLOBULIN LIGHT CHAIN KIT
- K880399 — V-TREND IM DRY-SPOT TEST
- K874328 — L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
- K874495 — ADCOMP 4000 HP SYSTEM
- K874623 — FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
- K874719 — STRATUM ESU
- K874805 — TATUNG'S DENTURE CLEANING SOLUTION
- K874836 — ABUSCREEN(R) EIA AMPHETAMINE
- K874863 — RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
- K875097 — DISPOSABLE SYRINGE
- K875105 — TECHNICON SMAC 3 SYSTEM
- K875155 — 60 ML RESERVOIR BAG, ITEM #200
- K875186 — IV EXTENSION SET
- K875349 — STERILE SURGICAL NATURAL LATEX GLOVES
- K880046 — HASTING FINGER FIXATOR INSTRUMENTS
- K880174 — JMS TRANSFUSION SET
- K880336 — MOBILIMB HAND C.P.M. UNIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.